Women account for over 10 million of the diagnosed incontinence cases. A majority of women dealing with incontinence suffer from stress urinary incontinence (“SUI”). Generally, women with SUI involuntarily lose urine during normal daily activities, such as laughing, coughing, and regular exercise.
Specifically, SUI is commonly caused by a functional defect of the tissue or ligaments connecting the vaginal wall with the pelvic muscles and pubic bone. Typical causes include repetitive straining of the pelvic muscles, childbirth, loss of pelvic muscle tone, and estrogen loss. These types of defects result in an improperly functioning urethra. Unlike other types of incontinence, SUI is not a problem of the bladder.
Normally, the urethra, when properly supported by strong pelvic floor muscles and healthy connective tissue, maintains a tight seal to prevent involuntary loss of urine. When a woman suffers from the most common form of SUI, however, weakened muscle and pelvic tissues are unable to adequately support the urethra in its correct position. As a result, during normal movements when pressure is exerted on the bladder from the diaphragm, the urethra cannot retain its seal, permitting urine to escape. Because SUI is both embarrassing and unpredictable, many women with SUI avoid an active lifestyle, shying away from social situations.
Non-operative treatment options for patients with SUI can be attempted, by instructing such patients to perform pelvic exercises, known as “Kegel” exercises, with the intention of strengthening the supporting muscles. However, when these exercises fail to reverse SUI, surgical repair is advised.
Among the many surgical options for SUI, the introduction into the abdominal cavity of a urethral “sling” has emerged in the past decade as the most effective. In this surgical procedure, the sling, typically in the form of a mesh or tape-like material, shaped like a flat ribbon, is passed through pelvic tissue and is positioned around the urethra and the bladder neck, forming a loop located between the urethra and the vaginal wall and thereby creating a supportive sling effect. The sling is extended over the pubis and through the abdominal wall and is tightened, after which the surplus material is cut and removed, and the sling is left implanted in the patient's abdominal cavity.
U.S. Pat. No. 5,899,909 discloses a treatment method and device for SUI. The device described, which allows a mesh or tape-like sling to be placed under the urethra, and includes two special needles. These are mounted in turn, by screw fastening, on a reusable steel insertion tool made of a handle and of a threaded manipulator rod, which allows each of the needles to be manipulated in turn. Each needle is fixed to one of the ends of the sling.
Often patients needing the surgical sling procedure are uncomfortable general anesthetic and would prefer the procedure be performed as an outpatient surgery with local anesthetic. It would therefore be beneficial to provide a surgical instrument for use in treating SUI that has a local anesthetic delivery system integrated therein. It would also be beneficial to provide a surgical instrument for use in treating SUI that allows the instrument operator to administer the local anesthetic with one hand, as it is often the case that a second hand is needed to guide the incising portion of the surgical instrument through the patient's abdominal fascia and soft tissue.
This invention addresses that need and advantageously overcomes the deficiencies of the prior art.